Evaluation of the Impact of a Food is Medicine Program on Diabetes-related Health Outcomes for People With Type 2 Diabetes in a Low Income Community-based Setting Compared to Usual Care

NCT07529184 | Completed

• 1 other identifier: I21-004
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if a food is medicine intervention (Healthy Food Rx) improves diabetes-related outcomes in adults diagnosed with type 2 diabetes in a low-income, community-based setting more than usual care. The main questions the study aims to answer are:

• Does Healthy Food Rx program participation lead to improved A1C values (a measure of glycemic control over approximately the past three months) over a 6-month period compared to usual care in a highly food insecure population?
• Does the Healthy Food Rx program lead to improved diabetes-related behaviors over a 6-month period compared to usual care in a highly food insecure population? Researchers will compare the Healthy Food Rx program to usual care to see if diabetes-related outcomes, including A1C, fruit and vegetable consumption, food security, physical activity, diabetes self-management behaviors and general physical and mental health status, improved more in those receiving Healthy Food Rx. Healthy Food Rx is a program that provides home-delivered, family-sized, recipe-based healthy food boxes with an approximate value of $40 every other week for 6 months to people with Type 2 diabetes living in Stockton, CA. Produce is sourced from local Central Valley growers, and the boxes also include pantry staples like chicken, fish, egg, beans and healthy snacks, such as nuts, yogurt, and cheese. Nutrition education opportunities are also provided to participants. Participants will:
• Complete surveys at two time points in either English or Spanish. The surveys last around 10 minutes and will be conducted by trained Health Educators.
• Provide HIPAA consent to allow researchers to obtain A1C values and demographic information from their medical record.
• Retest A1C around the conclusion of the study. Intervention participants will receive Healthy Food Rx immediately following enrollment and the control group will receive Healthy Food Rx at the end of the study.

Conditions

Diabetes (DM)

Keywords

food is medicine; randomized controlled trial; food security; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  A1C is a measure of glycemic control over approximately the past three months. Measures will be extracted from patient's medical records with HIPAA consent.

  They will be measured at 2 points in time. Baseline value is valid up to 3 months before enrollment Follow-up, A1C measures are valid from 60 days before to 90 days after the last food box delivery.

Secondary Outcomes (8)

• Food insecurity

  Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.

• Fruit consumption

  Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.

• Vegetable consumption

  Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.

• Water consumption

  Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.

• Physical activity

  Measured in baseline and follow-up surveys at enrollment and approximately 6 months after enrollment.

Study Arms (2)

Intervention group

EXPERIMENTAL

This group will receive Healthy Food Rx after enrollment.

Dietary Supplement: Food is medicine

Control group

NO INTERVENTION

This group will not receive Healthy Food Rx during the study, however they will receive Healthy Food Rx after the study conclusion.

Interventions

Food is medicine DIETARY_SUPPLEMENT

Healthy Food Rx provides family-sized, recipe-based healthy food boxes with an approximate value of $40 every other week for 6 months. The boxes are home-delivered and complementary nutrition education opportunities are provided to participants. Produce is sourced from local Central Valley growers, and the boxes include pantry staples like chicken, fish, egg, beans and healthy snacks, such as nuts, yogurt, and cheese.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (over age 18)
• Diagnosed with Type 2 diabetes
• Residing in Stockton, CA
• Recent (within previous 3 months) A1C above 7%
• Patient of study site clinic

You may not qualify if:

• previous program participant
• no home address to receive the food boxes
• unable to receive text messages

Sponsors & Collaborators

• Public Health Institute Center for Wellness and Nutrition: lead
• Abbott Fund: collaborator
• Community Medical Centers: collaborator
• Emergency Food Bank of Stockton: collaborator

Study Sites (1)

Community Medical Centers

Stockton, California, 95210, United States

Location

Related Links

• Results from the previous study without a comparison group.

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Evaluation

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 14, 2026
• Study Start: January 16, 2024
• Primary Completion: January 21, 2025
• Study Completion: January 21, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)